CHICAGO, IL, October 6, 2009 --/WORLD-WIRE/-- Anti-aging skin products are known as cosmeceuticals, as they overlap the distinction between cosmetics and pharmaceuticals. These products are the fastest growing sales sector of the entire cosmetics industry, and are widely marketed as being safe. But Cancer Prevention Coalition Chairman Dr. Samuel S. Epstein warns that altering the physical structure of skin with chemicals to look more youthful comes at a hidden price to the skin, and even more so to overall health.

The term cosmeceutical, applied to anti-wrinkle and anti-aging creams, was first adopted by the cosmetics industry in 1984. It was developed as a way to avoid subjecting the industry’s claims to the authority of the Food and Drug Administration (FDA). The idea was to create a new category of products that did more than just improve the appearance of the skin, yet do somewhat less than pharmaceutical drugs.

But Dr. Epstein wants to alert consumers to the dangers of cosmeceuticals, including the increased risk of skin cancer.

In addition, he is urging the new FDA Commissioner Margaret Hamburg, M.D. to take “appropriate regulatory action to protect the unsuspecting public from the dangers of cosmeceuticals.”

Here is what we know of the overwhelming majority of cosmeceuticals, says Dr. Epstein, based on toxicology and clinical testing.

To increase the permeability of skin, hydroxy acids are widely sold on store shelves and used in cosmetic salons. Both alpha-hydroxy acids (AHA), and beta-hydroxy acids (BHA) are common ingredients in cosmeceuticals.

Worse still, Dr. Epstein warns, AHAs are used in an estimated 5 percent of all products without any labeling to this effect.

Even the industry’s Cosmetics Ingredient Review Compendium has admitted that these ingredients strip the skin of its protective surface, which absorbs long-wave ultraviolet radiation from sunlight and tanning salons.

Apart from increased risks of sunburn, exposure to AHAs also increases risks of a dangerous skin cancer, known as malignant melanoma. Although it is one of the less common types of skin cancer, malignant melanoma is responsible for roughly 75 percent of all skin cancer-related deaths.

Reacting to these concerns, in 1992 the FDA issued a consumer warning that products containing these ingredients “could destroy the upper layers of skin, causing severe burns, swelling and pain.” However, the FDA took no regulatory action to protect consumers, and the agency still has taken no regulatory action, Dr. Epstein points out.

Bisabolol is another cosmeceutical ingredient which strips off the surface layers of skin. This chemical is also a penetration enhancer, meaning that it increases the absorption of cosmeceutical ingredients through the skin.

Limonene is also a common ingredient in anti-aging products. “Apart from being an irritant, it is a well documented carcinogen,” says Dr. Epstein.

Parabens are commonly added to cosmeceuticals as preservatives. However, Dr. Epstein cautions consumers that even when tested at low concentrations on the skin of pregnant rodents, parabens induce toxic hormonal effects in male embryos and infants.

“Nano-particles are more recent and ultra-dangerous ingredients in cosmeceuticals, particularly anti-wrinkle creams,” warns Dr. Epstein. “By reducing the size of ingredients to the ultra-microscopic scale, they penetrate readily and deeply through the skin into the blood and organs all over the body.”

“Ninety percent of all cosmetics sold in the world today are probably cosmeceuticals,” says Dr. Albert Kligman, the dermatologist who first coined the term, in a 2005 interview with the journal Dermatologic Surgery.

“The terminology regarding the distinction between cosmetics and drugs is a marketing game in the U.S.," Kilgman said. "If you reverse aging, you are a drug. If you smooth skin, you are a cosmetic. Categorization depends more on the language on the bottle rather than the product in the bottle.”

Dr. Epstein says, “These statements raise troubling concerns regarding the identity and safety of ingredients in cosmeceutical products. So many women, and even some men, slather these products all over their skin, the largest body organ, in the naïve belief that they have nothing to fear but aging.”

“The industry markets cosmeceuticals with anecdotal or even wild claims of effectiveness, rather than scientific data, and with reckless disregard for safety,” Dr. Epstein cautions.

He points to a 2007 warning from the respected Mayo Clinic that cosmeceuticals have rarely been tested for safety, and also that they may contain “powerful active ingredients that can affect biological processes.”

Cosmeceutical manufacturers “make a calculated decision not to make claims that will result in scrutiny by the U.S. Food and Drug Administration of the product as a drug,” stated Dr. Mary P. Lupo of the Tulane University School of Medicine in a 2005 issue of Dermatologic Surgery. “Clinical testing could also draw the attention of the FDA, so some manufacturers opt instead to allow the consumer arena to become the test market.”

“So there you have it!” Dr. Epstein says, “People who use cosmeceuticals are guinea pigs in reckless and self-serving industry experiments to test whether these products are safe for human health. This should be a loud siren wakeup warning for anyone who still believes that these products have been tested for toxicity by the industry, and approved by the FDA.”

In spite of these disturbing concerns, dermatologist Dr. Nicholas Perricone, author of three New York Times best selling books, is an active proponent of a “Men’s Skin Care Line,” his patented product based on nanoparticles.

Apart from the ineffectiveness of the great majority of cosmeceutical products, most are highly priced. In 2006, Consumer Reports magazine evaluated anti-wrinkle creams on the market, and concluded there was no correlation between price and possible effectiveness. “The best advice is prevent those wrinkles in the first place,” read the review. “Stay out of the sun and don’t smoke.”

Dr. Epstein says that the cosmeceutical product Restylane is an exception to his warnings. “This Swedish anti-wrinkling agent is based on the natural ingredient hyaluronic acid, one of the very few scientifically proven safe and effective cosmeceuticals,” he says.

Besides Botox injections, which have been on the market long enough to be accepted as safe, there are emerging green alternatives to the wide range of conventional anti-aging products now on store shelves.

Dr. Epstein says these include natural botanicals, such as date palm oil, which have been found to be safe and effective for certain types of wrinkles, and topical green tea cream, which has proven effective for treating sun damaged skin.

Dr. Epstein anticipates that Dr. Hamburg, the highly respected new FDA Commissioner, will take appropriate regulatory action to protect the unsuspecting public from the dangers of cosmeceuticals.

Samuel S. Epstein, M.D. is professor emeritus of Environmental and Occupational Medicine at the University of Illinois at Chicago School of Public Health; Chairman of the Cancer Prevention Coalition; The Albert Schweitzer Golden Grand Medalist for International Contributions to Cancer Prevention; and author of over 200 scientific articles and 15 books on cancer, including the groundbreaking The Politics of Cancer (1979), and Toxic Beauty (2009).